Tengchuang Ma, Presenter: Nothing to Disclose

Hai Bo Shao MD, Abstract Co-Author: Nothing to Disclose

Long Gao, Abstract Co-Author: Nothing to Disclose

Hongying Su, Abstract Co-Author: Nothing to Disclose

Xu Ke MD, Abstract Co-Author: Nothing to Disclose

To evaluate the efficacy and safety of arsenic trioxide (As2O3) contained transcatheter arterial chemoembolization (TACE) for treatment of unresectable hepatocellular carcinoma (HCC).

A multicenter randomized controlled trial was conducted on 223 patients with unresectable HCC at twelve tertiary referral center hospitals between January 2007 and December 2010. Patients were randomly assigned to three groups with different intra-procedure drug administration protocols (group 1: TACE-As2O3 20mg, n=69; group 2: TACE-epirubicin 40mg, n=71; group 3: TACE-two drugs combined, n=83). All TACE procedures were carried out by superselective embolization using drug-lipiodol emulsion. Repeated TACEs (mean 2.8 times) were performed at one-month intervals and followed up at three-month intervals. Therapeutic effect was evaluated by mRICIST criterion. The primary end point was overall survival (OS). The secondary end point was time to progression (TTP). Adverse effect (AE) observation obeyed CTCAE 4.0.1 version. Survival analysis was performed with Kaplan-Meier method by Log-rank test. Factors associated with OS and TTP were also analyzed.

There were no treatment-related deaths. By follow-up of 6 to 43 months, there was no significant difference in OS among three groups (16.0, 15.6, 17.2 months in group 1, 2 and 3, p=0.5614). However, TTP in group1 (12.9 months) and group 3 (13.8 months) was significantly longer than that in group 2 (7.7 months, P<0.01). Multivariate analysis showed that BCLC stage was an independent prognostic factor for OS and TTP. Intra-procedure drug administration protocol was a prognostic factor for TTP. On stratification analysis, As2O3 contained TACE (group 1 and 3) showed longer OS (P<0.001) and TTP (P<0.001) in patients in BCLC B stage. The proportion of Ⅲ-Ⅳ AEs in group 2 and 3 was significantly higher than that in group 1 (liver function abnormalities, P<0.05; Ⅲ degree toxicity incidence ,P <0.05).

As2O3 contained TACE improved TTP of the patients with unresectable HCC, especially the patients in BCLC B stage (both OS and TTP were prolonged). The toxicity of TACE was not increased for single or combined use of As2O3.

As2O3 contained TACE may prolong TTP and OS of unresectabe HCC especially in BCLC B stage without enhancement of toxicity.

Ma, T, Shao, H, Gao, L, Su, H, Ke, X, Arsenic Trioxide Contained Transcatheter Arterial Chemoembolization for Treatment of Unresectable Hepatocellular Carcinoma: A Prospective Multicenter Randomized Controlled Trial.  Radiological Society of North America 2014 Scientific Assembly and Annual Meeting, - ,Chicago IL. http://archive.rsna.org/2014/14010237.html